NCT06380660

Study of ACE-86225106 to Treat Patients With Advanced Solid Tumors

A Phase I/II, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of ACE-86225106 as Monotherapy in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 298 (estimated)
• Sponsor: Acerand Therapeutics (Shanghai) Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if the experimental treatment with poly-ADP ribose polymerase (PARP) inhibitor, ACE-86225106 is safe, tolerable and has anti-cancer activity in adult patients with advanced solid tumors.

Detailed description

This study is a Phase I/II, open-label, multicentre study of ACE-86225106 administered orally in patients with advanced solid tumors.

Conditions

• Solid Tumor, Adult
• BRCA1 Mutation
• BRCA2 Mutation
• Ovarian Cancer
• Breast Cancer
• Prostate Cancer

Interventions

Type	Name	Description
DRUG	ACE-86225106 tablet	ACE-86225106 will be administered orally daily as a continuous regimen. Subjects will continue to receive study treatment until PD as judged by local investigator review, development of unacceptable toxicity, or withdrawal of consent.

Timeline

• Start date: 2024-03-22
• Primary completion: 2028-12-21
• Completion: 2029-03-21
• First posted: 2024-04-24
• Last updated: 2025-12-29

Locations

14 sites across 1 country: China